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NCT01537029 · ClinicalTrials.gov registry record · Phase 4
Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
A Phase 4 study, sponsored by Texas Tech University Health Sciences Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT01537029 is a Phase 4 study that has completed, run by Texas Tech University Health Sciences Center. The registered enrollment target is 15 participants.
The verdict
NCT01537029, a Phase 4 study, has completed, sponsored by Texas Tech University Health Sciences Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
To determine the effect of weight on doxorubicin and cyclophosphamide plasma clearance in participants who are normal weight (body mass index \[BMI\] \< 25 kg/m2, overweight or class I obese (BMI 25-34.9 kg/m2), or class II-III obese (BMI ≥ 35 kg/m2). The hypothesis is that participants who weigh more will have higher doxorubicin and cyclophosphamide clearances than participants who weigh less. Restated, the area under the drug-concentration time profile, also known as the AUC, in participants will decrease as participant weight increases.
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2012-02 |
| Est. Completion | 2016-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01537029
The ClinicalTrials.gov registry entry for NCT01537029 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Texas Tech University Health Sciences Center, which has 76 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cyclophosphamide is the first listed.
NCT01537029 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01537029 about?
NCT01537029 is a clinical study titled "Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide". To determine the effect of weight on doxorubicin and cyclophosphamide plasma clearance in participants who are normal weight (body mass index \[BMI\] \< 25 kg/m2, overweight or class I obese (BMI 25-34.9 kg/m2), or class II-III obese (BMI ≥ 35 kg/m2). The hypothesis is that participants who weigh mo...
What is the current status of trial NCT01537029?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2012-02. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01537029?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG).
Who is sponsoring clinical trial NCT01537029?
This trial is sponsored by Texas Tech University Health Sciences Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
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